Is there a generic for Methylphenidate hydrochloride?

Yes. The FDA Orange Book lists 72 approved generic (ANDA) applications for Methylphenidate hydrochloride, referencing the brand RELEXXII. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Methylphenidate hydrochloride?

RELEXXII (NDA 216117, OSMOTICA PHARM US) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Methylphenidate hydrochloride?

The Orange Book lists 49 patents against Methylphenidate hydrochloride products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Methylphenidate hydrochloride are approved?

Methylphenidate hydrochloride is approved in the following dosage forms: capsule, extended release, for suspension, extended release, solution, tablet, tablet, chewable, tablet, extended release, tablet, extended release, chewable.

FDA Orange Book · active-ingredient family

Methylphenidate hydrochloride

Methylphenidate hydrochloride: 13 brands, 72 generics; first approved Mar 30, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 72 ANDA applications approved.

Earliest patent expiry Mar 15, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Mar 15, 2027

in 5 mo

Brand (NDA) products

Originator applications

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RELEXXIIRLD

OSMOTICA PHARM USNDA 21611720227 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
18MG	TABLET, EXTENDED RELEASE	ORAL	Rx	-
27MG	TABLET, EXTENDED RELEASE	ORAL	Rx	-
36MG	TABLET, EXTENDED RELEASE	ORAL	Rx	-
45MG	TABLET, EXTENDED RELEASE	ORAL	Rx	-
54MG	TABLET, EXTENDED RELEASE	ORAL	Rx	-
63MG	TABLET, EXTENDED RELEASE	ORAL	Rx	-
72MG	TABLET, EXTENDED RELEASE	ORAL	Rx	-

ADHANSIA XRRLD

KNOA PHARMANDA 21203820196 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	-
35MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	-
45MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	-
55MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	-
70MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	-
85MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	-

JORNAY PMRLD

IRONSHORE PHARMSNDA 20931120185 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	-
40MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	-
60MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	-
80MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	-
100MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	-

QUILLICHEW ERRLD

NEXTWAVE PHARMSNDA 20796020153 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET, EXTENDED RELEASE, CHEWABLE	ORAL	Rx	-
30MG	TABLET, EXTENDED RELEASE, CHEWABLE	ORAL	Rx	-
40MG	TABLET, EXTENDED RELEASE, CHEWABLE	ORAL	Rx	-

APTENSIO XRRLD

RHODES PHARMSNDA 20583120157 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB3
15MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB3
20MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB3
30MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB3
40MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB3
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB3
60MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB3

QUILLIVANT XRRLDRS
NEXTWAVENDA 2021002012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML FOR SUSPENSION, EXTENDED RELEASE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	FOR SUSPENSION, EXTENDED RELEASE	ORAL	Rx	AB

RITALIN LARLD

SANDOZNDA 02128420045 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
30MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
40MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
10MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
60MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	-

METADATE CDRLD

LANNETTNDA 02125920036 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
30MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
10MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
40MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
60MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2

METHYLINRLD
SPECGX LLCNDA 02147520033 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET, CHEWABLE ORAL Discontinued -
5MG TABLET, CHEWABLE ORAL Discontinued -
10MG TABLET, CHEWABLE ORAL Discontinued -
METHYLINRLDRS
SPECGX LLCNDA 02141920022 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/5ML SOLUTION ORAL Rx AA
10MG/5ML SOLUTION ORAL Rx AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET, CHEWABLE	ORAL	Discontinued	-
5MG	TABLET, CHEWABLE	ORAL	Discontinued	-
10MG	TABLET, CHEWABLE	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/5ML	SOLUTION	ORAL	Rx	AA
10MG/5ML	SOLUTION	ORAL	Rx	AA

CONCERTARLD

JANSSEN PHARMSNDA 02112120004 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
18MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
36MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
54MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
27MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

RITALIN-SRRLD
NOVARTISNDA 0180291982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET, EXTENDED RELEASE ORAL Discontinued -
RITALINRLD
SANDOZNDA 010187-3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Generic (ANDA) products (72)

Abbreviated applications

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METHYLPHENIDATE HYDROCHLORIDE
SUN PHARM INDS INCANDA 2172292023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
72MG TABLET, EXTENDED RELEASE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
72MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

METHYLPHENIDATE HYDROCHLORIDE

ALKEM LABS LTDANDA 21444720234 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
18MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
27MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
36MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
54MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

METHYLPHENIDATE HYDROCHLORIDE

RHODES PHARMSANDA 21411120224 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
18MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
27MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
36MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
54MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-

METHYLPHENIDATE HYDROCHLORIDE
ASCENT PHARMS INCANDA 20741720212 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/5ML SOLUTION ORAL Rx AA
10MG/5ML SOLUTION ORAL Rx AA
METHYLPHENIDATE HYDROCHLORIDE
CHARTWELL MOLECULARANDA 20741420202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/5ML SOLUTION ORAL Discontinued -
10MG/5ML SOLUTION ORAL Discontinued -
METHYLPHENIDATE HYDROCHLORIDE
ACCORD HLTHCAREANDA 21393620203 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
METHYLPHENIDATE HYDROCHLORIDE
ALKEM LABS LTDANDA 2122882020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET, EXTENDED RELEASE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/5ML	SOLUTION	ORAL	Rx	AA
10MG/5ML	SOLUTION	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/5ML	SOLUTION	ORAL	Discontinued	-
10MG/5ML	SOLUTION	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

METHYLPHENIDATE HYDROCHLORIDE

SUN PHARM INDS INCANDA 20513520204 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
18MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
27MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
36MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
54MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-

METHYLPHENIDATE HYDROCHLORIDE

GRANULESANDA 21347320204 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
18MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
27MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
36MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
54MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

METHYLPHENIDATE HYDROCHLORIDE
PRINSTON INCANDA 21269720203 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
METHYLPHENIDATE HYDROCHLORIDE
QUAGENANDA 21356720202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/5ML SOLUTION ORAL Rx AA
10MG/5ML SOLUTION ORAL Rx AA
METHYLPHENIDATE HYDROCHLORIDE
ANDA REPOSITORYANDA 21076420202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/5ML SOLUTION ORAL Rx AA
10MG/5ML SOLUTION ORAL Rx AA
METHYLPHENIDATE HYDROCHLORIDE
ALKEM LABS LTDANDA 21164720202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/5ML SOLUTION ORAL Rx AA
10MG/5ML SOLUTION ORAL Rx AA
METHYLPHENIDATE HYDROCHLORIDE
ALKEM LABS LTDANDA 21177920193 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/5ML	SOLUTION	ORAL	Rx	AA
10MG/5ML	SOLUTION	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/5ML	SOLUTION	ORAL	Rx	AA
10MG/5ML	SOLUTION	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/5ML	SOLUTION	ORAL	Rx	AA
10MG/5ML	SOLUTION	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

METHYLPHENIDATE HYDROCHLORIDE

ASCENT PHARMS INCANDA 21100920194 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
18MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
27MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
36MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
54MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

METHYLPHENIDATE HYDROCHLORIDE
STRIDES PHARMA INTLANDA 20465920192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
36MG TABLET, EXTENDED RELEASE ORAL Discontinued -
54MG TABLET, EXTENDED RELEASE ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
36MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
54MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-

METHYLPHENIDATE HYDROCHLORIDE

GRANULESANDA 21179620195 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
20MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
30MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
40MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
60MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1

METHYLPHENIDATE HYDROCHLORIDE

ANDOR PHARMSANDA 21191820194 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
18MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
27MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
36MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
54MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

METHYLPHENIDATE HYDROCHLORIDE
CEDIPROF INCANDA 20873720193 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

METHYLPHENIDATE HYDROCHLORIDE

ACTAVIS ELIZABETHANDA 20886120187 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB3
15MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB3
20MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB3
30MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB3
40MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB3
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB3
60MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB3

METHYLPHENIDATE HYDROCHLORIDE

ALVOGENANDA 21081820184 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
18MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
27MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
36MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
54MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-

METHYLPHENIDATE HYDROCHLORIDE
GRANULESANDA 21099220182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET, EXTENDED RELEASE ORAL Rx AB
20MG TABLET, EXTENDED RELEASE ORAL Rx AB
METHYLPHENIDATE HYDROCHLORIDE
AUROLIFE PHARMA LLCANDA 20927620183 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -
10MG TABLET ORAL Discontinued -
20MG TABLET ORAL Discontinued -
METHYLPHENIDATE HYDROCHLORIDE
HIBROW HLTHCAREANDA 21013920182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/5ML SOLUTION ORAL Rx AA
10MG/5ML SOLUTION ORAL Rx AA
METHYLPHENIDATE HYDROCHLORIDE
ACTAVIS LABS FL INCANDA 2060492018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/ML FOR SUSPENSION, EXTENDED RELEASE ORAL Rx AB
METHYLPHENIDATE HYDROCHLORIDE
ACTAVIS LABS FLANDA 07677220183 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
18MG TABLET, EXTENDED RELEASE ORAL Rx AB
27MG TABLET, EXTENDED RELEASE ORAL Rx AB
36MG TABLET, EXTENDED RELEASE ORAL Rx AB
METHYLPHENIDATE HYDROCHLORIDE
ACTAVIS LABS FLANDA 07665520182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
54MG TABLET, EXTENDED RELEASE ORAL Rx AB
72MG TABLET, EXTENDED RELEASE ORAL Rx AB
METHYLPHENIDATE HYDROCHLORIDE
BIONPHARMAANDA 20975320183 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
METHYLPHENIDATE HYDROCHLORIDE
DR REDDYS LABS SAANDA 2008862018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG CAPSULE, EXTENDED RELEASE ORAL Rx AB1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
20MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	-
10MG	TABLET	ORAL	Discontinued	-
20MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/5ML	SOLUTION	ORAL	Rx	AA
10MG/5ML	SOLUTION	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/ML	FOR SUSPENSION, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
54MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
72MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

METHYLPHENIDATE HYDROCHLORIDE

AMNEAL PHARMSANDA 20751520184 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
18MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
27MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
36MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
54MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-

METHYLPHENIDATE HYDROCHLORIDE
ASCENT PHARMS INCANDA 21035420173 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET, CHEWABLE ORAL Rx AB
5MG TABLET, CHEWABLE ORAL Rx AB
10MG TABLET, CHEWABLE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET, CHEWABLE	ORAL	Rx	AB
5MG	TABLET, CHEWABLE	ORAL	Rx	AB
10MG	TABLET, CHEWABLE	ORAL	Rx	AB

METHYLPHENIDATE HYDROCHLORIDE

OSMOTICA PHARM USANDA 20532720175 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
18MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
27MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
36MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
54MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
72MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

METHYLPHENIDATE HYDROCHLORIDE

ANI PHARMSANDA 20860720174 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
18MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
27MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
36MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
54MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-

METHYLPHENIDATE HYDROCHLORIDE
ABHAI LLCANDA 20693220173 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
METHYLPHENIDATE HYDROCHLORIDE
MPP PHARMAANDA 20758720173 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -
10MG TABLET ORAL Discontinued -
20MG TABLET ORAL Discontinued -
METHYLPHENIDATE HYDROCHLORIDE
QUAGENANDA 20495420173 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET, CHEWABLE ORAL Discontinued -
5MG TABLET, CHEWABLE ORAL Discontinued -
10MG TABLET, CHEWABLE ORAL Discontinued -
METHYLPHENIDATE HYDROCHLORIDE
ABHAI LLCANDA 20748520162 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/5ML SOLUTION ORAL Rx AA
10MG/5ML SOLUTION ORAL Rx AA
METHYLPHENIDATE HYDROCHLORIDE
RISINGANDA 20575620163 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET, CHEWABLE ORAL Rx AB
5MG TABLET, CHEWABLE ORAL Rx AB
10MG TABLET, CHEWABLE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB
10MG	TABLET	ORAL	Rx	AB
20MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	-
10MG	TABLET	ORAL	Discontinued	-
20MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET, CHEWABLE	ORAL	Discontinued	-
5MG	TABLET, CHEWABLE	ORAL	Discontinued	-
10MG	TABLET, CHEWABLE	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/5ML	SOLUTION	ORAL	Rx	AA
10MG/5ML	SOLUTION	ORAL	Rx	AA

METHYLPHENIDATE HYDROCHLORIDE

AUROLIFE PHARMA LLCANDA 20672620164 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
18MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
27MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
36MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB
54MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB

METHYLPHENIDATE HYDROCHLORIDE
ALVOGENANDA 20684020163 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -
10MG TABLET ORAL Discontinued -
20MG TABLET ORAL Discontinued -

METHYLPHENIDATE HYDROCHLORIDE

IMPAX LABS INCANDA 20510520166 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
20MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
30MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
40MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
60MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2

METHYLPHENIDATE HYDROCHLORIDE
ALVOGENANDA 20477220162 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET, EXTENDED RELEASE ORAL Discontinued -
20MG TABLET, EXTENDED RELEASE ORAL Discontinued -
METHYLPHENIDATE HYDROCHLORIDE
NOVEL LABS INCANDA 20788420153 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB

METHYLPHENIDATE HYDROCHLORIDE

SPECGX LLCANDA 20358320156 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
20MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
30MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
40MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2
60MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB2

METHYLPHENIDATE HYDROCHLORIDE
ASCENT PHARMS INCANDA 20741620153 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
METHYLPHENIDATE HYDROCHLORIDE
NOVEL LABS INCANDA 20460220152 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/5ML SOLUTION ORAL Rx AA
10MG/5ML SOLUTION ORAL Rx AA
METHYLPHENIDATE HYDROCHLORIDE
ABHAI LLCANDA 20748820152 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET, EXTENDED RELEASE ORAL Rx AB
20MG TABLET, EXTENDED RELEASE ORAL Rx AB
METHYLPHENIDATE HYDROCHLORIDE
NOVEL LABS INCANDA 20411520153 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET, CHEWABLE ORAL Discontinued -
5MG TABLET, CHEWABLE ORAL Discontinued -
10MG TABLET, CHEWABLE ORAL Discontinued -

METHYLPHENIDATE HYDROCHLORIDE

BARR LABS INCANDA 07903120144 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	-
30MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	-
40MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	-
10MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	-

METHYLPHENIDATE HYDROCHLORIDE
OXFORD PHARMSANDA 20289220143 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
METHYLPHENIDATE HYDROCHLORIDE
MOUNTAINANDA 09115920143 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -
10MG TABLET ORAL Discontinued -
20MG TABLET ORAL Discontinued -
METHYLPHENIDATE HYDROCHLORIDE
NOVITIUM PHARMAANDA 20146620132 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/5ML SOLUTION ORAL Discontinued -
10MG/5ML SOLUTION ORAL Discontinued -

METHYLPHENIDATE HYDROCHLORIDE

LANNETT CO INCANDA 09169520134 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
18MG	TABLET, EXTENDED RELEASE	ORAL	Rx	BX
27MG	TABLET, EXTENDED RELEASE	ORAL	Rx	BX
36MG	TABLET, EXTENDED RELEASE	ORAL	Rx	BX
54MG	TABLET, EXTENDED RELEASE	ORAL	Rx	BX

METHYLPHENIDATE HYDROCHLORIDE

SPECGX LLCANDA 20260820123 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
27MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
36MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-
54MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	-

METHYLPHENIDATE HYDROCHLORIDE
TEVA PHARMSANDA 07770720123 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG CAPSULE, EXTENDED RELEASE ORAL Rx AB2
20MG CAPSULE, EXTENDED RELEASE ORAL Rx AB2
30MG CAPSULE, EXTENDED RELEASE ORAL Rx AB2

METHYLPHENIDATE HYDROCHLORIDE

TEVA PHARMSANDA 07887320123 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	-
50MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	-
60MG	CAPSULE, EXTENDED RELEASE	ORAL	Discontinued	-

METHYLPHENIDATE HYDROCHLORIDE
SUN PHARM INDS INCANDA 09071020123 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB

METHYLPHENIDATE HYDROCHLORIDE

DR REDDYS LABS SAANDA 07845820114 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
30MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
40MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1
60MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	AB1

METHYLPHENIDATE HYDROCHLORIDE
TRIS PHARMA INCANDA 09160120102 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/5ML SOLUTION ORAL Rx AA
10MG/5ML SOLUTION ORAL Rx AA
METHYLPHENIDATE HYDROCHLORIDE
ACTAVIS ELIZABETHANDA 04032120023 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -
10MG TABLET ORAL Discontinued -
20MG TABLET ORAL Discontinued -
METHYLPHENIDATE HYDROCHLORIDE
HERITAGE PHARMAANDA 0754502001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET, EXTENDED RELEASE ORAL Discontinued -
METHYLPHENIDATE HYDROCHLORIDE
ABLEANDA 0760322001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET, EXTENDED RELEASE ORAL Discontinued -
METHYLPHENIDATE HYDROCHLORIDE
ABLEANDA 04040420013 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -
10MG TABLET ORAL Discontinued -
20MG TABLET ORAL Discontinued -
METHYLPHENIDATE HYDROCHLORIDE
WATSON LABSANDA 0404102001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET, EXTENDED RELEASE ORAL Discontinued -
METHYLIN ER
SPECGX LLCANDA 07562920002 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET, EXTENDED RELEASE ORAL Rx AB
20MG TABLET, EXTENDED RELEASE ORAL Rx AB
METADATE ER
LANNETT CO INCANDA 0403061999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET, EXTENDED RELEASE ORAL Discontinued -
METHYLPHENIDATE HYDROCHLORIDE
SPECGX LLCANDA 04030019983 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Rx AB
10MG TABLET ORAL Rx AB
20MG TABLET ORAL Rx AB
METHYLPHENIDATE HYDROCHLORIDE
WATSON LABSANDA 04022019973 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -
10MG TABLET ORAL Discontinued -
20MG TABLET ORAL Discontinued -
METADATE ER
LANNETT CO INCANDA 0896011988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET, EXTENDED RELEASE ORAL Discontinued -
METHYLPHENIDATE HYDROCHLORIDE
LANNETT CO INCANDA 086429-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG TABLET ORAL Discontinued -
METHYLPHENIDATE HYDROCHLORIDE
LANNETT CO INCANDA 085799-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TABLET ORAL Discontinued -
METHYLPHENIDATE HYDROCHLORIDE
LANNETT CO INCANDA 086428-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG TABLET ORAL Discontinued -

Patent & exclusivity timeline

Protection horizon

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Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Ask AI

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8202537	Mar 15, 2027	in 5 mo	Product
8062667	Mar 29, 2029	in 2 yr 6 mo	Product
8465765	Feb 15, 2031	in 4 yr 5 mo	ProductU-1415
8778390	Feb 15, 2031	in 4 yr 5 mo	ProductU-1543
8956649	Feb 15, 2031	in 4 yr 5 mo	ProductU-1665
8563033	Feb 15, 2031	in 4 yr 5 mo	ProductU-1415
9040083	Feb 15, 2031	in 4 yr 5 mo	Product
8287903	Feb 15, 2031	in 4 yr 5 mo	Product
10292937	Mar 23, 2032	in 5 yr 6 mo	U-2357
9603809	Mar 23, 2032	in 5 yr 6 mo	U-2357
8916588	Mar 23, 2032	in 5 yr 6 mo	U-2357
9028868	Mar 23, 2032	in 5 yr 6 mo	U-2357
10617651	Mar 23, 2032	in 5 yr 6 mo	U-2357
9034902	Mar 23, 2032	in 5 yr 6 mo	U-2357
10881618	Mar 23, 2032	in 5 yr 6 mo	U-2357
11911518	Mar 23, 2032	in 5 yr 6 mo	U-2357
11241391	Mar 23, 2032	in 5 yr 6 mo	U-2357
11241392	Mar 23, 2032	in 5 yr 6 mo	Product
9498447	Mar 23, 2032	in 5 yr 6 mo	Product
9283214	Mar 23, 2032	in 5 yr 6 mo	Product
9023389	Mar 23, 2032	in 5 yr 6 mo	Product
10905652	Mar 23, 2032	in 5 yr 6 mo	Product
8927010	Mar 23, 2032	in 5 yr 6 mo	Product
10182995	Mar 23, 2032	in 5 yr 6 mo	Product
9295642	Aug 14, 2033	in 6 yr 11 mo	ProductU-1827
11103495	Aug 14, 2033	in 6 yr 11 mo	ProductU-2993
9545399	Aug 14, 2033	in 6 yr 11 mo	ProductU-1827
9844544	Aug 14, 2033	in 6 yr 11 mo	ProductU-2203
10857143	Aug 14, 2033	in 6 yr 11 mo	ProductU-2993
11103494	Aug 14, 2033	in 6 yr 11 mo	Product
8999386	Aug 14, 2033	in 6 yr 11 mo	Product
11633389	Aug 14, 2033	in 6 yr 11 mo	Product
10292939	Oct 30, 2035	in 9 yr 2 mo	ProductU-2357
10512613	Oct 30, 2035	in 9 yr 2 mo	U-2357
10449159	Oct 30, 2035	in 9 yr 2 mo	U-2357
10500162	Oct 30, 2035	in 9 yr 2 mo	U-2357
10568841	Oct 30, 2035	in 9 yr 2 mo	ProductU-2357
10111839	Oct 30, 2035	in 9 yr 2 mo	U-2357
10292938	Oct 30, 2035	in 9 yr 2 mo	Product
10507186	Oct 30, 2035	in 9 yr 2 mo	Product
10688060	Oct 30, 2035	in 9 yr 2 mo	Product
10512612	Oct 30, 2035	in 9 yr 2 mo	Product
9974752	Oct 30, 2035	in 9 yr 2 mo	Product
10695336	Feb 03, 2037	in 10 yr 5 mo	U-4032
10265308	Feb 03, 2037	in 10 yr 5 mo	ProductU-4032
9855258	Feb 03, 2037	in 10 yr 5 mo	ProductU-4032
9827234	Feb 03, 2037	in 10 yr 5 mo	U-4032
9707217	Feb 03, 2037	in 10 yr 5 mo	Product
10722473	Nov 19, 2038	in 12 yr 3 mo	U-2357

Approval history

FDA approval span

Ask AI

First approval

Mar 30, 1982

45 yr 3 mo ago

Most recent approval

Aug 25, 2023

3 yr 3 mo ago

Approvals span 1982–2023 across 85 FDA applications.

Brand (NDA) 1315%

Generic (ANDA) 7285%

Methylphenidate hydrochloride: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Ask AI about Methylphenidate hydrochloride

Key facts

Active ingredient: Methylphenidate hydrochloride
Brand (NDA): 13
Generic (ANDA): 72
Reference-listed drug: RELEXXII
Dosage forms: CAPSULE, EXTENDED RELEASE, FOR SUSPENSION, EXTENDED RELEASE, SOLUTION, TABLET, TABLET, CHEWABLE, TABLET, EXTENDED RELEASE, TABLET, EXTENDED RELEASE, CHEWABLE
Routes: ORAL
TE codes: AA, AB, AB1, AB2, AB3, BX
Earliest patent expiry: Mar 15, 2027